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NCT02069327 Clinical Trial

The Role of Fat Emboli in the Trauma Inflammatory Response

Femoral Fracture Clinical Trial

Official title:
The Role of Fat Emboli in the Trauma Inflammatory Response

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02069327
Other study ID # Fat Emboli
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2012
Est. completion date November 2014

Study information
Verified date March 2019
Source Poudre Valley Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is an observational study designed to investigate the role of fat emboli in patients who are undergoing a tibial or femoral fracture procedure in the operating room. The purpose of this study is to obtain samples of bone marrow and blood during tibial or femoral fracture procedures to understand the inflammatory response.

Description:

Bone marrow is routinely removed during a tibial or femoral fracture procedure; researchers will take samples for this study from bone marrow that has already been removed as part of this procedure. No additional marrow samples will be taken as part of this research study. Also, researchers will collect blood (about 4 teaspoons) for testing inflammatory response and coagulation. Researchers may need to insert an additional line to collect your blood.

Recruitment information / eligibility
Status Completed
Enrollment 9
Est. completion date November 2014
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients undergoing a tibial or femoral fracture procedure in the operating room.

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Medical Center of the Rockies Loveland Colorado

Sponsors (2)
Lead Sponsor Collaborator
Poudre Valley Health System Colorado State University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Inflammatory Response Samples will be tested using proteomic and metabolomic assays from samples of bone marrow reamed during intramedullary (IM) femoral nailing.
Blood samples drawn at the time of IM nailing will be tested to determine if clinically relevant amounts of marrow containing these inflammatory mediators are released into the bloodstream.		 One day
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